Cholesterol

Enzymatic Esterase--oxidase, Cholesterol

RANDOX LABORATORIES, LTD.

The following data is part of a premarket notification filed by Randox Laboratories, Ltd. with the FDA for Cholesterol.

Pre-market Notification Details

Device IDK150654
510k NumberK150654
Device Name:Cholesterol
ClassificationEnzymatic Esterase--oxidase, Cholesterol
Applicant RANDOX LABORATORIES, LTD. 55 DIAMOND ROAD Crumlin,  GB Bt29 4qy
ContactPauline Armstrong
CorrespondentPauline Armstrong
RANDOX LABORATORIES, LTD. 55 DIAMOND ROAD Crumlin,  GB Bt29 4qy
Product CodeCHH  
CFR Regulation Number862.1175 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2015-03-13
Decision Date2015-09-29
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414596327 K150654 000

Trademark Results [Cholesterol]

Mark Image

Registration | Serial
Company
Trademark
Application Date
CHOLESTEROL
CHOLESTEROL
73837165 1611220 Dead/Cancelled
KSF MEDICAL PUBLISHING COMPANY, INC.
1989-11-09
CHOLESTEROL
CHOLESTEROL
73783518 not registered Dead/Abandoned
DAWN FOOD PRODUCTS, INC.
1989-02-27
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